New FDA Waived Tests

The following tests are approved by the FDA as waived tests under the CLIA.

CPT Code Modifier Effective Date Description
86318QW December 09, 2004 Germaine Laboratories, Aimstep H. pylori {whole blood}
87807QW January 28, 2005 Binax Now RSV Test (K032166/A005)
81003QW February 18, 2005 Physician Sales & Service, Inc. PSS Select Urine Analyzer
87880QW March 08, 2005 McKesson Medi-Lab Performance Strep A Test Dipstick
86308QW March 08, 2005 Clearview Mono-Plus II
86318QW March 08, 2005 Wampole Laboratories Clearview H. pylori II (finger stick or whole blood)
87899QW March 16, 2005 Genzyme OSOM Trichomonas Rapid Test
86308QW March 16, 2005 McKesson Medi-lab Performance Infectious Mononucleosis Test
83721QW March 25, 2005 Polymer Technology Systems Cardiochek PA Analyzer
87880QW April 21, 2005 Biotechnostix Rapid Response Strep A Rapid Test Strip
87880QW April 21, 2005 Biotechnostix Rapid Response Strep A Rapid Test Device
87880QW April 21, 2005 RAC Medical Clarity Strep A Rapid Test Strips
80101QW June 03, 2005 Acon One Step Multi-Drug, Multi-Line Screen Test Device (Professional Use)

Note: The tests mentioned on the first page of the Attachment included with CR3984 (i.e., CPT codes: 81002, 81025, 82270, G0107, 82962, 83026, 84830, 85013, and 85651) do not require a QW modifier to be recognized as a waived test.

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